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Regulatory Submissions Webinars

Life Sciences companies frequently experience lengthy approval delays as they bring new products to market. Today, submissions to multiple regulatory bodies are often prepared and submitted through a manual, paper-based process whereby managing the lifecycle, tracking changes, assembling and submitting the right data can be a challenge. These webinars review different submission requirements from eCTD and labeling to Clinical Disclosure Transparency.

Documents

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Best Practices for SPL R4 Compliance Best Practices for SPL R4 Compliance

Guest Speaker: Satish Tadikonda, President, Virtify, Inc.

Enabling Electronic Submissions to Accelerate Product Approvals and Time to Market Enabling Electronic Submissions to Accelerate Product Approvals and Time to Market

Guest Speakers: Satish Tadikonda, President, Virtify, Inc. and Ikram Baig, Chief Technology Officer, Virtify, Inc.

Lessons Learned from the implementation of eCTD in Canada, Europe and U.S. Lessons Learned from the implementation of eCTD in Canada, Europe and U.S.

Guest Speaker: Helen Teichman, President, Chestnut Solutions Inc.

Optimizing the Clinical Trials Disclosure Process Optimizing the Clinical Trials Disclosure Process

Guest Speaker: Satish Tadikonda, President, Virtify, Inc.